Peppermint Oil for the treatment of Irritable Bowel Syndrome or Functional Abdominal Pain in Children: the MINT study - the MINT trial

St Antonius Hospital0 个研究点目标入组 240 人开始时间: 2021年9月21日最近更新: 2021年11月15日

适应症

试验速览

暂无简介。

•Children aged between 8 and 18 years
•Diagnosis of IBS or FAP-NOS according to the Rome IV criteria
•Exclusion of underlying organic disorders after routine laboratory testing initiated by their general practitioner or treating physician as part of standard of care
•In patients without alarm symptoms only celiac screening (anti-transglutaminase antibodies and IgA), and faecal calprotectin are necessary.37 In patients with diarrhea faecal testing for Giardia Lambliae will be added. If alarm symptoms are present, further diagnostic testing (like a full blood count, CRP, liver tests or an ultrasound) to rule out an organic disorder, is left to the discretion of the treating physician.
•An average daily pain rate of =2 on the Wong Baker Faces Pain Scale (This is a validated pain scale to measure pain intensity).36
•Informed Consent by both parents and by children aged = 12 years. No informed consent from parents is necessary for children >16 years.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 240
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Current treatment by another health care professional for abdominal symptoms
•Previous use of peppermint oil for abdominal complaints
•Known hypersensitivity to mints or peppermint oil
•Gastrointestinal blood loss
•Recurrent or unexplained fevers
•Decreased growth velocity
•History of previous abdominal surgeries in the past 3 months
•Significant chronic health condition requiring specialty care (e.g., lithiasis, ureteropelvic junction obstruction, sickle cell, cerebral palsy, hepatic, hematopoietic, renal, endocrine, or metabolic diseases) that could potentially impact the child’s ability to participate or confound the results of the study
•Known concomitant organic gastrointestinal disease
•Current use of drugs which influence gastrointestinal motility, such as erythromycin, azithromycin, butyl scopolamine, domperidone, mebeverine and Iberogast. If laxatives are being used (in patients with IBS-C) they can continue using them during the study.
•Current use of proton-pump inhibitors
•Insufficient knowledge of the Dutch language
•Pregnancy or current lactation.

发起方